The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.
Full Title of Study: “A Randomised, Double-blind, Double-dummy, Multi-centre, Comparative Parallel-group Study to Evaluate the Efficacy and Safety of Oral Daily Rifamycin SV-MMX® 400 mg b.i.d. vs. Ciprofloxacin 500 mg b.i.d. in the Treatment of Acute Infectious Diarrhoea in Travellers”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: January 2016
- Drug: Rifamycin SV-MMX®
- 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
- Drug: Ciprofloxacin
- 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
Arms, Groups and Cohorts
- Experimental: Group A
- Rifamycin SV-MMX® 200 mg tablets
- Active Comparator: Group B
- Ciprofloxacin 500 mg capsules
Clinical Trial Outcome Measures
- Time to Last Unformed Stool (TLUS)
- Time Frame: 5 days
- Time to Last Unformed Stool (TLUS), defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared.
- Number of Patients With Clinical Cure
- Time Frame: 5 days
- Clinical Cure Rate: 24-hour period with no clinical symptoms except mild flatulence, no fever, no watery stools and no more than 2 soft stools OR 48-hour period with no stools or only formed stools, and no fever, with our without symptoms of enteric infection.
Participating in This Clinical Trial
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 85 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Provider of Information About this Clinical Study
- Overall Official(s)
- Professor Robert Steffen, M. D., Principal Investigator, University of Zurich, Switzerland
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